UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment: Case report
Title of the study (Brief title)	Botulinum toxin in Behcet's disease
Region	Japan

Condition
Condition	Behcet's disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To report a unique case in which subcutaneous injections of botulinum toxin to treat axillary hyperhidrosis appeared to trigger acute uveitis in a patient with Behcet's disease even though his condition had been stable while he received periodic infliximab treatment. The patient received his regularly scheduled infliximab injection, and the uveitis resolved quickly.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	An ultra-widefield high-resolution digital image of fundus, anterior chamber flare, best corrected visual acuity, and intraocular pressure were measured before and after the Botulinum toxin-induced acute uveitis.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A patient with Behcet's disease in which injections of botulinum toxin appeared to trigger uveitis even though his condition had been stable while he received periodic infliximab treatment.
Key exclusion criteria	None.
Target sample size	1

Research contact person
Name of lead principal investigator	Masahiro Zako
Organization	Asai hospital
Division name	Department of Ophthalmology
Address	178-1 Yakata-cho, Seto, Aichi
TEL	0561843111
Email	mzako@aol.com

Public contact
Name of contact person	Masahiro Zako
Organization	Asai hospital
Division name	Department of Ophthalmology
Address	178-1 Yakata-cho, Seto, Aichi
TEL	0561843111
Homepage URL
Email	mzako@aol.com

Sponsor
Institute	Department of Ophthalmology Asai hospital
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人宏和会あさい病院（愛知県）/Asai Hospital (Aichi Prefecture)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2016 Year 09 Month 01 Day
Date of closure to data entry	2016 Year 09 Month 02 Day
Date trial data considered complete	2016 Year 09 Month 03 Day
Date analysis concluded	2016 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To examine Botulinum toxin-induced uveitis in a patient with Behcet's disease under infliximab treatment

Management information
Registered date	2016 Year 09 Month 01 Day
Last modified on	2016 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027511